Percutaneous Access Needles

• Chiba tip
• 18-gauge and 22-gauge options
• 20 cm length

Indications

Puncture of the renal cavities.

Contraindications

Some percutaneous renal procedures may be contraindicated in the following situations (unless the

anticipated benefits outweigh the potential risks):

• Uncontrolled haemostasis disorders.
• Untreated urinary tract infection.
• Malignant kidney or urinary tract tumor.

Do not use when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions

• The 22-gauge needle does not allow passage of conventional 0.035- or 0.038-inch guidewires
• Do not withdraw the guidewire through the needle, as this can damage the guidewire. If the guidewire needs to be withdrawn, remove the guidewire and the needle as a unit
• The risks and benefits of using Chiba needles should be considered in patients

Adverse Events

The use of this device may be associated with several risks including, but not limited to:

• Bleeding/hematuria
• Damage (perforation) to the kidney, urinary tract or neighboring organs, particularly if the instructions for use have not been complied with, and especially if the procedure has been performed without image guidance control.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.

For Rx Only

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Minneapolis, MN

05/28/2020